Fibromyalgia Musculoskeletal Diseases
Conditions
Interventions
This study has a single-centre, double-blind, randomized, double-dummy, 3-period, crossover design (18 weeks/participant) to compare a melatonin-pregabalin combination to each monotherapy in participa
Sponsors
Canadian Institutes of Health Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants =18 years old and over meeting the 2016 American College of Rheumatology diagnostic criteria for fibromyalgia 2. Daily moderate pain (= 3/10) for at least 3 months 3. Liver function test, ALT, no greater than 20% above normal 4. Creatinine clearance >50 mL/min 5. Sufficient cognitive function and language comprehension skills – regardless of native language – for questionnaire completion and communication with trial personnel (and translator, if necessary) 6. Women of childbearing potential will be required to receive a highly effective form of contraception
Exclusion criteria
Exclusion criteria: 1. Participants with any major organ system disease, psychiatric, suicidal ideation or substance abuse disorder, which, in the opinion of the investigators, would interfere with trial participation 2. Hypersensitivity to any of the study medications 3. Other painful conditions as severe as fibromyalgia pain 4. Shift workers who work during typical sleeping hours 5. Any other abnormalities or conditions that, in the judgement of the investigators would interfere with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean of “average” pain intensity self-ratings at the maximally tolerated dose of each treatment period measured using a Likert numerical rating scale twice daily over the last 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Review of adverse events and concurrent analgesic treatments measured by monitoring of study records throughout screening (pre-trial), baseline (pre-trial), during each treatment period (titration period, maximal tolerated dose and taper/washout), and 2 weeks and 3 months after the end of the trial 2. Pain intensity measured using pain diaries at baseline (pre-trial), during each treatment period (titration period, maximal tolerated dose and taper/washout), and 2 weeks after the end of the trial 3. Study medication dose levels and patient global impression of change during each treatment period (titration period, maximal tolerated dose and taper/washout) 4. Drug dispensing; Medical Outcomes Study (MOS); Brief Pain Inventory (BPI); Beck Anxiety Inventory (BAI); the MOS 36-item shortform health survey (SF-36) and the Fibromyalgia Impact Questionnaire (FIQ) at baseline (pre-trial) and the maximal tolerated dose during each treatment period 5. Vital signs, height, weight and Beck Depression Inventory - 2 (BDI-2) at screening (pre-trial) and the maximal tolerated dose during each treatment period 6. Pain (average and worst) measured using the Present Pain Intensity (PPI) (0-10 numerical scale), demographics, medical history and clinical laboratory assessments at screening (pre-trial) 7. Blinding questionnaire, drug compliance at the maximal tolerated dose during each treatment period | — |
Countries
Canada
Contacts
Public ContactIan Gilron
Outcome results
None listed